RFP 75D30123R72635 Combined Synopsis Solicitation CDC PPRL.pdf

RFP# 75D301-23-R-72635

SECTION A – SYNOPSIS AND DESCRIPTION OF REQUIREMENT

This is a combined synopsis/solicitation for commercial items prepared in accordance with the format in

Subpart 12.6. This announcement constitutes the only solicitation. Proposals are being requested, and a written solicitation will not be issued. The solicitation number is 75D301-23-R-72635, and is being issued as a request for proposals (RFP). The solicitation document and incorporated provisions and clauses are those in effect through Federal Acquisition Circular FAC 2023-02. The associated North American Industrial Classification System (NAICS) code for this procurement is 513210 Software Publishers.

THIS RFP IS BEING SOLICITED AS A TOTAL SMALL BUSINESS SET-ASIDE.

Offerors must be registered in the System for Award Management (SAM) at http://www.sam.gov in order to be considered for award.

This combined synopsis solicitation notice is a request for competitive proposals. This requirement is for de-identified healthcare data and may result in the award of one Firm Fixed Price contract. The term of the resulting contract shall be twenty-four (24) months comprised of a base period of twelve (12) months followed by one (1) twelve (12) month option period. A Government review of performance will be performed annually through the Contractor Performance Assessment Reporting System (CPARS), which provides timely and relevant information on Contractor performance for use in source selection. The anticipated Period of Performance for this requirement and any resultant contract, inclusive of all option periods, is 09/23/2023 – 09/22/2025.

All questions/inquiries must be submitted to the contracting officer via electronic mail (e-mail) no later than 12:00 PM EDT on Monday, 05/08/2023. Inquiries via telephone will be re-directed to an e-mail submission. Submit offers and/or any questions to the attention of Michael Crow at wyv2@cdc.gov. Questions will not be answered on an individual basis, and all responses will be posted to www.sam.gov.

Proposals are due via email to wyv2@cdc.gov no later than 5:00 PM EDT on Wednesday, 05/31/2023.

Offerors who fail to complete and submit a proposal in accordance with the requirements of this combined synopsis/solicitation may be considered non-responsive at the discretion of the Contracting Officer and will not be considered for award. Only proposals received prior to the RFP closing date and time will be considered by the CDC. Late proposals will not be accepted.

https://acquisition.gov/far/current/html/Subpart%2012_6.html#wp1088488 http://www.sam.gov/ mailto:wyv2@cdc.gov.

http://www.sam.gov/ mailto:wyv2@cdc.gov

TABLE OF CONTENTS

Issued 05/01/2023

Section Document/Clause/Provision Page No.

A Synopsis and Description of Requirement 1 B Supplies or Services and Prices/Costs 3 C Statement of Work 9 D Contract Clauses 18 E Contract Documents, Exhibits or Attachments 32 F Solicitation Provisions 33 G Additional Instructions 36

SECTION B – SUPPLIES OR SERVICES AND PRICES/COSTS

ITEM SUPPLIES / SERVICES QTY / UNIT UNIT PRICE EXTENDED PRICE

0001 Privacy-Preserving Record Linkage (PPRL) of

Patient-Level Real World Healthcare Data, Comprehensive Data Cohort:

Task 1

This is a Severable Firm Fixed Price Line Item.

Period of Performance: 09/23/2023 – 09/22/2024.

12 Each

0002 CDC-specified Disease- or Syndromic-specific Cohorts:

Task 2

This is a Severable Firm Fixed Price Line Item.

Period of Performance: 09/23/2023 – 09/22/2024.

1 Each

0003 Race/Ethnicity Data and Other Relevant Social Determinant of Health Information:

Task 3

This is a Severable Firm Fixed Price Line Item.

Period of Performance: 09/23/2023 – 09/22/2024.

1 Each

0004 Mother/Baby Cohort:

Task 4

This is a Severable Firm Fixed Price Line Item.

Period of Performance: 09/23/2023 – 09/22/2024.

4 Each

0005 Linkage of Additional Laboratory Data:

Task 5

This is a Severable Firm Fixed Price Line Item.

Period of Performance: 09/23/2023 – 09/22/2024.

4 Each

0006 Data Dictionaries and Metadata:

Task 6

This is a Severable Firm Fixed Price Line Item.

Period of Performance: 09/23/2023 – 09/22/2024.

1 Each

0007 PPRL Training Services:

Task 7

This is a Severable Firm Fixed Price Line Item.

Period of Performance: 09/23/2023 – 09/22/2024.

12 Each

0008 Bridge Files for Linkage to Other Relevant Public Health Information:

Task 8

This is an Optional Line Item that may be exercised pursuant to Section B.1 at any time during the listed Period of Performance.

This is a Severable Firm Fixed Price Line Item.

Period of Performance: 09/23/2023 – 09/22/2024.

12 Months

Option Year 1 Items:

1001 Privacy-Preserving Record Linkage (PPRL) of

Patient-Level Real World Healthcare Data, Comprehensive Data Cohort:

Task 1

This is a Severable Firm Fixed Price Line Item.

Period of Performance: 09/23/2024 – 09/22/2025.

12 Each

1002 CDC-specified Disease- or Syndromic-specific Cohorts:

Task 2

This is a Severable Firm Fixed Price Line Item.

Period of Performance: 09/23/2024 – 09/22/2025.

1 Each

1003 Race/Ethnicity Data and Other Relevant Social Determinant of Health Information:

Task 3

This is a Severable Firm Fixed Price Line Item.

Period of Performance: 09/23/2024 – 09/22/2025.

1 Each

1004 Mother/Baby Cohort:

Task 4

This is a Severable Firm Fixed Price Line Item.

Period of Performance: 09/23/2024 – 09/22/2025.

4 Each

1005 Linkage of Additional Laboratory Data:

Task 5

This is a Severable Firm Fixed Price Line Item.

Period of Performance: 09/23/2024 – 09/22/2025.

4 Each

1006 Data Dictionaries and Metadata:

Task 6

This is a Severable Firm Fixed Price Line Item.

Period of Performance: 09/23/2024 – 09/22/2025.

1 Each

1007 PPRL Training Services:

Task 7

This is a Severable Firm Fixed Price Line Item.

Period of Performance: 09/23/2024 – 09/22/2025.

12 Each

1008 Bridge Files for Linkage to Other Relevant Public Health Information:

Task 8

This is an Optional Line Item that may be exercised pursuant to Section B.1 at any time during the listed Period of Performance.

This is a Severable Firm Fixed Price Line Item.

Period of Performance: 09/23/2024 – 09/22/2025.

12 Months

Summary of Pricing Base Period Option Period 1 Total:

B.1 Optional Tasks Line Items – CLINs 0008 and 1008:

Optional task line items, CLINs 0008 and 1008, may only be exercised once up to the total extended price listed per

CLIN.

The Contracting Officer may exercise the optional task line items by written notice to the Contractor within the period of performance of the CLIN associated with the optional line item, as shown in the schedule above. The exact period of performance for the optional task will be established at the time it is exercised and may be for a different period of time than other line items in this contract.

The contractor will be notified in writing, by letter or email, at least 15 days before the option is exercised. After that written notification, a funded, unilateral modification will be issued to actually exercise the option or options. The period of performance and total value/funding will be based on the number of months remaining in the applicable contract period.

The Government reserves the right not to exercise any optional task CLINs if no optional tasks are required during the performance of this contract.

B.2 Points of Contact:

Contractor: TBD Telephone:

Email:

CDC/PHIC: TBD

Telephone:

Email:

CDC/OAS: Michael Crow Telephone: (770) 488-3208 Email: wyv2@cdc.gov mailto:wyv2@cdc.gov

SECTION C – STATEMENT OF WORK

C.1 BACKGROUND:

Access to timely and comprehensive data on the spread and impact of infectious diseases and emerging public health concerns remains critical to understanding and combatting public health threats such as the COVID-19 pandemic, the 2022 monkeypox outbreak, 2022 polio/acute flaccid myelitis, among others. The U.S. Centers for Disease Control and Prevention (CDC) utilizes electronic healthcare data for public health purposes to inform situational awareness, predictive modeling, and strategic, tactical, and policy decision making; to help track the spread and intensity of outbreak infections and identify areas that are highly impacted by disease; to understand spectrum of illness, disease burden, risk factors for severe disease, and outcomes; and to understand the impact of COVID-19 and other public health threats on healthcare systems and communities.

Ideally, in critical public health moments, such as the COVID-19 pandemic and 2022 monkeypox outbreak, data on individuals can be leveraged from a closed system to longitudinally identify all the medical touchpoints and tests to specifically define and inform on the public health problem. Currently, there are no data sources available with national coverage that are comprehensive and able to provide a detailed record on individuals necessary for surveillance. An alternative to accessing a closed single source of data is to have the ability to combine multiple data sources into a longitudinal, interoperable, real-world healthcare data view. This type of comprehensive data is uniquely suited to provide novel insight into new and emerging priority questions related to SARS-CoV-2 variants, vaccinations, testing, re-infection, health impact, natural history, and long-term effects of COVID-19.

Similarly, these data sources could be leveraged to better understand healthcare utilization and outcomes of other public health threats such as monkeypox outbreaks.

C.2 PURPOSE:

The purpose of this contract is to obtain a large volume (>75 million individuals or larger) of deidentified, patient-level, real world, national level (including data from all 50 states, District of Columbia, and, ideally, U.S. territories) healthcare data that is interoperable and can be linked across medical and pharmacy claims (including both open and closed systems), hospital chargemaster data, electronic medical record (EMR), and laboratory data at the patient-level using privacy-preserving record linkage (PPRL). Optimally, these data shall be representative of the health events captured in the data of the U.S. population at the national and regional level (and ideally at the sub-regional level) or the data shall have weights that can be applied to transform the data to be representative.

The required data will have been drawn from a variety of US data sources, including provider-submitted claims, adjudicated insurance claims, electronic medical records, pharmacy information systems, hospital billing (e.g., charge-master (CDM) data), and laboratory information systems. More specifically, the required data shall contain data from the following sources:

Medical claims data: These data shall include two primary types 1) those that reflect a patient’s medical event (e.g., visit date and diagnosis), and 2) those that reflect activity from the data provider (adjudication status). These shall include data from the continuum of care that includes outpatient (ambulatory care), telehealth visits, urgent care, emergency department, inpatient stays (hospitalizations), and post-acute care settings such as long-term acute care (LTAC) settings and long-term care facilities (LTCF). The data shall encompass medical visits, outpatient and inpatient procedures, surgeries, prescriptions, vaccinations, and other interventions.

Pharmacy data: These data shall include health plan data and individual patient-level dispensing data from pharmacies, pharmacy system vendors, clearinghouses, and pharmacy benefit managers. The data shall encompass medications, vaccinations, and other medical countermeasures that may be dispensed.

Electronic Medical Records: These data shall include patient demographics (e.g., age, sex, race, and ethnicity), diagnoses, medications, lab and imaging results, clinical observations (including vitals), patient reported problems, allergies, and, optimally, unstructured data elements like clinical notes, radiology reports, scanned documents, and image files as needed.

Laboratory Test Data: These data shall include information from clinical laboratories, with pathology and genomic laboratory tests encompassed. Data shall include the test order, the result, dates associated with the test order and result, and if available, the interpretation and interpretive range for the result.

Hospital Chargemaster Data: These data collected from hospital billing systems and chargemaster systems shall include visit-level diagnoses, procedures, and specific drug/product/resource utilization by date of service and/or day of stay (versus higher level visit utilization that would be available on claims only), inpatient source of admission, location of care by day of stay (ER, IP, ICU, etc.), length of stay, discharge disposition, and inpatient lab results (when available). Having information on insurance status and type, as well as cost of care, overall and at the patient level, would be optimal.

Priority characteristics of data provided pursuant to this contract include the following:

1. The data shall include substantial volumes patients/visits occurring in all 50 U.S. states, District of

Columbia, and, preferably, U.S. Territories. Optimally, the data will be representative or will have weights that enable generation of analytic results that are representative of the outcomes of interest (e.g., hospitalizations) at the national and regional (and ideally, sub-regional) levels.

2. The data shall incorporate unique identifiers that enable linking of all information for each unique patient across the various data sets (including electronic medical records, medical claims, pharmacy transactions, and laboratory test orders and results) following the patient through the care continuum.

3. The data shall have capability to link patients’ information longitudinally that enable discerning the timeline of events and better understand patient demographic and clinical characteristics and outcomes associated with different diseases and conditions.

4. The data shall have capability to link, while preserving privacy and minimizing risk of re-identification, the core data deliverables to other external laboratory data and data owned or stewarded by the US government that has had keys established using similar PPRL technologies.

5. The data shall follow acceptable data standardization principles and criteria (e.g., related to content definitions, categories, and formats). This can include components of the data being organized by using common data models such as the Observational Medical Outcomes Partnership (OMOP) standard.

6. The data shall have capability to support clinical and epidemiologic studies using longitudinal patient records to assess co-morbidities, clinical severity, and disease sequelae, in the form of descriptive analyses, case-control and cohort studies, and test-negative design studies.

7. The data shall have capability to support research related to social determinants of health (SDOH) and health equity, diversity, and inclusion. This includes providing information on community-level social determinants of health (e.g., Social Vulnerability Index metrics in their typical format or summarized to specific preserve privacy and minimize risk of re-identification) that are linked at the patient level based on patients’ US Census tract, ZIP Code, or county of residence.

8. The data shall include a sufficient number of patients with each of all major payer types (including government insurance providers) and can include information on persons without health insurance.

Ideally, information on insurance status and type shall be included in the data.

9. The data shall include geographic information for patients and providers whereby analytic results can be generated below the state level and by rural/urban location status.

10. The data shall allow for a cohort of mom-baby linkages from patients receiving care in closed systems.

11. The data shall support and assessment of changes in testing and management patterns for infectious disease, like hepatitis and HIV, as well as prescription medication use and adherence to treatment among patients over the course of the public health threat (e.g., to assess indirect effects of COVID-19 mitigation strategies on changes in healthcare seeking behavior).

12. The data shall support an examination of vaccination patterns and the use of new therapeutics for vaccine and medication effectiveness and duration of protection.

13. The data shall include medical costs related information, including charges and payment information, and include costs incurred by payers as well as patients.

14. Ideally, data shall incorporate free text information, such as from clinical notes, that can be mined for additional clinically relevant information using natural language processing and related techniques.

This data source has high impact potential for the CDC emergency responses and surveillance efforts for future responses because it offers CDC scientists and the emergency response task force personnel the opportunity to conduct complex analysis and develop use-cases on disease patterns, progression, and health outcomes; evaluate clinical guidelines uptake, treatments, and interventions; and conduct public health surveillance type queries. A longitudinal, interoperable, real world healthcare data can fill multiple gaps in CDC’s current healthcare data portfolio and can be used to address numerous priorities or questions in the CDC Science Agenda. These data shall include keys, also described as tokens or UNIQUE PATIENT IDs, that link clinical variables such as laboratory values, biometric information, prescriptions, diagnoses, and therapeutic outcomes, that can be used to develop insights based on provider patient treatment decisions and health outcomes. PPRL data is a novel and innovative data source that can be used for addressing COVID-19 and emerging public health priorities for any CDC Emergency Response Task Force and any related CDC Operational Division.

C.3 SCOPE OF WORK:

The contractor shall deliver monthly analysis-ready PPRL data that will be managed and analyzed in the CDC’s cloud environment. Delivery of the data set shall include all applicable records from the contractor’s ecosystem for all patients with one or more unique patient ID assignments between December 2018 and the current date. The data shall encompass medical claims, pharmacy data, electronic medical records, lab data, hospital chargemaster data, which includes patient demographic features like race/ethnicity data, with some geographic granularity, like state, 5-digit zip code, etc. The contractor shall include keys to link variables such as clinical measures, laboratory values, prescriptions, diagnoses, vaccinations, and therapeutic outcomes, with data dictionaries within data sources or centralized databases and between data sources or decentralized databases through the unique patient ID.

The contractor’s data shall include critical data including disease provider diagnoses, patients reported problems and symptoms, testing for SARS-CoV-2 or other infectious diseases (NAAT and/or antibody), and treatments with therapeutic products. These treatment-specific data shall be capable of integration with other information in electronic health records, longitudinal medical and pharmacy claims and other diverse data sources with central or decentralized databases. The contractor shall also provide training and professional services relating specifically to the data provided pursuant to this contract.

CDC shall retain the ability to use the data extracts received during each 12-month contract period following contract completion and will dispose of the data thereafter in accordance with applicable Federal records management policies.

C.4 TASKS TO BE PERFORMED:

Task 1 - Comprehensive Data Cohort:

The data ecosystem for this task includes data for medical claims, pharmacy claims, chargemaster, laboratory and EMR data sources.

The contractor shall provide CDC with linking software, license, and data science technology that allows the contractor to activate any CDC data source that contains Protected Health Information or Personally Identifiable Information (PHI/PII), and map it to a unique patient ID, while preserving patient privacy management and Health Insurance Portability and Accountability Act (HIPAA) compliance. The linking software shall be delivered once during the base year, and updates shall be provided as they become available during the base year and any exercised option years.

For a large, representative catchment of the US population (>75 million population), the contractor shall include all recorded data from December 2018 forward, for all available medical claims (including insurance provider and type), pharmacy claims (including insurance provider and type), chargemaster, and EMR data in the data ecosystem. The contractor shall deliver analysis-ready unique patient ID linked data that are interoperable using a token. The unique patient ID shall be linkable a) longitudinally over time and b) within specific data sources, and C) across different data sources.

These data shall be delivered monthly during the base year and any exercised option years.

Task 2 - CDC-specified Disease or Syndromic-specific Cohorts:

The contractor shall provide CDC with the data ecosystem for patients who have been tested for (negative or positive result), treated for, or diagnosed with COVID-19 or other priority surveillance-indicated disease states, or who have symptoms or syndrome indications (fever, cough, shortness of breath or difficulty breathing, fatigue, sore throat, muscles or body aches, headache and or new loss of normal-state function) reported in a medical encounter.

For this task, patients shall be included in the data offering if they are (1) diagnosed with COVID or other priority surveillance-indicated disease states, diagnosed with related symptoms for the priority surveillance-indicated disease state, tested for SARS-CoV-2 (e.g., Rapid Antigen, NAAT, and/or antibody tests; positive or negative result) or another priority infectious surveillance indicated disease, treated with COVID or other related treatment or therapeutic products.

These data shall be delivered once during the base year and any exercised option years.

Task 3 - Race/Ethnicity Data and Other Relevant Social Determinant of Health Information:

Patient race and ethnicity data elements may be in separate data sets, to preserve HIPAA compliance. However, such data should be linkable to other provided data to enable race and ethnicity based aggregate results. The contractor shall utilize EMR claims or other source records to deliver patient race and ethnicity data to CDC in an interoperable, HIPAA compliant manner.

Crosswalk-enabled deliverables shall be developed by allowing CDC to connect patient race and ethnicity data to medical claims, pharmacy claims, chargemaster, EMR and laboratory data from Task 1 with the unique patient ID.

To ensure data provided are HIPAA compliant, the contractor shall propose, where necessary, options related to data availability, access, and use when providing race and ethnicity data. Doing so will ensure that all data delivered to the CDC are de-identified in compliance with HIPAA regulations. These crosswalk-enabled deliverables shall be delivered in the same frequency as the corresponding task across the base and option year if exercised.

Furter, additional data elements will be provided that allows CDC to conduct research related to social determinants of health and health equity, diversity, and inclusion. This can include individual-level data available within the vendor’s data ecosystem, as well as community-level social determinants of health information (e.g., Social Vulnerability Index metrics in their typical format or summarized to specific preserve privacy and minimize risk of re-identification) that are linked at the patient level based on patients’ US Census tract, ZIP Code, or county of residence.

These data shall be delivered once during the base year and once during any exercised option years.

Task 4 - Mother/Baby Cohort:

The contractor shall deliver comprehensive HIPAA-compliant crosswalk-enabled deliverables that includes unique patient IDs to link mothers and their babies together. The data shall be developed out of the closed claims only.

Using this crosswalk, the contractor shall deliver Mom/Baby deliverables to CDC. These deliverables shall provide a linkage showing the maternal and infant relationship and shall link to medical claims, pharmacy claims, chargemaster, EMR and lab data where that same unique patient ID is identified. The data shall update regularly to allow CDC to follow these pairs prospectively across the other data cohorts.

The contractor shall deliver analysis-ready unique patient ID linked crosswalk enabled deliverable files with two unique patient IDs showing the maternal-infant relationship. These mom/baby crosswalk-enabled deliverables link mothers and their infants together through patient specific unique patient IDs that can in turn be connected to RWD to better understand and study outcomes of mothers and their infants across the cohorts established in Tasks 1–3.

These data shall be delivered quarterly during the base year and quarterly during any exercised option years.

Task 5 - Linkage of Additional Laboratory Data:

For SARS-Cov-2 or other laboratory testing data not currently in the contractor’s data ecosystem, the contractor shall establish a relationship with the data source(s) and deploy a Census engine within the laboratory’s system to create a unique patient ID de-identified HIPAA compliant token using the laboratory’s protected PHI/PII information. In that way, protected PHI/PII information remains within the protected environment of the data supplier, and is removed for reporting, leaving only the de-identified unique patient ID token. For the NAAT/PCR tests that are identified for genomic sequencing, the unique patient ID token shall be available within the genomic sequencing test records to crosswalk to the unique patient ID information in the contractor’s data ecosystem. The tokenization technology shall be deployed once in the base year and once for any exercised option years if updates become available.

These data shall be delivered quarterly during the base year and quarterly during any exercised option years.

Task 6 - Data Dictionaries and Metadata:

The contractor shall provide data dictionaries for medical claims, pharmacy claims, chargemaster, laboratory and EMR data sources, and shall update as appropriate. Data dictionaries shall be delivered once during the base year and once for any exercised option years, with any updates as needed if data schema and definitions are modified or updated.

Metadata and additional data provenance information shall be provided with each data delivery that captures key information about the data source, including the origin, changes to and details critical to supporting the confidence and validation of the data. Ideally, this information would be transmitted electronically and be able to be ingested into CDC’s Enterprise Data Catalogue to ensure the data are findable for potential agency users.

These data shall be delivered once during the base year and once during any exercised option years.

Task 7 – Training Services:

Trainings shall be presented live and shall be provided remotely (via video- or tele-conference). Training content shall be jointly determined by the contractor and CDC in advance. Examples of training content include best practices for variables in the relational datasets, insight to understand inconsistencies in similar variables across datasets, and scenarios when one variable is preferable over another. Training sessions shall last between 4 and 8 hours each.

The contractor shall provide up to twelve (12) trainings on data assets per 12-month contract period, to include the base year and each exercised option year.

Optional Task 8 - Bridge Files for Linkage to Other Relevant Public Health Information:

The contractor shall provide a bridge file that contains (a) the unique patient IDs for patients within the data deliverables in the different cohorts and (b) the PPRL unique LinkID for all individuals within other data sources that have undergone PPRL as part of the contractor’s work with the U.S. Department of Health and Human Services. For example, the USG COVID-19 vaccination data sources, which are inclusive of federal data such as Federal Pharmacy Program, Indian Health Service, Veterans’ Administration data and jurisdictional data (e.g., state or territorial immunization information systems [IIS]), and commercial laboratory data that can include genomic sequencing data.

The bridge file deliverable shall be developed by pairing PPRL LinkIDs with the corresponding patient IDs, allowing CDC to connect individual vaccination records to (1) medical claims, pharmacy claims, chargemaster, EMR, and laboratory data from Tasks 1, 2, and 5 and to (2) closed pharmacy claims and laboratory data from Task 3.

These data shall be delivered monthly for any exercised contract period.

C.5 DELIVERABLES/REPORTING:

Contract Task Associated Deliverable Required Frequency

Task 1 Comprehensive Data Cohort Monthly

Task 2

CDC-specified Disease- or Syndromic-specific Cohorts

Once per contract period, within 10 business days of contract award and within 10 business days following the beginning of any exercised option period.

Task 3

Race/Ethnicity Data and Other Relevant Social Determinant of Health Information

Within 5 business days of contract award and within 5 business days following the beginning of any exercised option period.

Task 4

Mother/Baby Cohort Quarterly

Task 5 Linkage of Additional Laboratory Data Quarterly

Task 6 Data Dictionaries and Metadata Once per contract period, within 10 business days of contract award and within 10 business days following the beginning of any exercised ti i d

Task 7

Training Services No greater than monthly, up to 12 times per contract period

Task 8 (Optional) Bridge Files for Linkage to Other Relevant Public Health Information

Monthly, based on the number of months exercised.

C.6 QUALITY ASSURANCE SURVEILLANCE PLAN:

C.7 ELECTRONIC AND INFORMATION TECHNOLOGY ACCESSIBILITY NOTICE:

(a) Section 508 of the Rehabilitation Act of 1973 (29 U.S.C. 794d), as amended by the Workforce Investment Act of 1998 and the Architectural and Transportation Barriers Compliance Board Electronic and Information (EIT) Accessibility Standards (36 CFR part 1194), require that when Federal agencies develop, procure, maintain, or use electronic and information technology, Federal employees with disabilities have access to and use of information and data that is comparable to the access and use by Federal employees who are not individuals with disabilities, unless an undue burden would be imposed on the agency. Section 508 also requires that individuals with disabilities, who are members of the public seeking information or services from a Federal agency, have access to and use of information and data that is comparable to that provided to the public who are not individuals with disabilities, unless an undue burden would be imposed on the agency.

(b) Accordingly, any offeror responding to this solicitation must comply with established HHS EIT accessibility standards. Information about Section 508 is available at http://www.hhs.gov/web/508. The complete text of the Section 508 Final Provisions can be accessed at http://www.access-board.gov/sec508/standards.htm.

(c) The Section 508 accessibility standards applicable to this solicitation are stated in the clause at 352.239-74, Electronic and Information Technology Accessibility.

In order to facilitate the Government's determination whether proposed EIT supplies meet applicable Section 508 accessibility standards, offerors must submit an HHS Section 508 Product Assessment Template, in accordance with its completion instructions. The purpose of the template is to assist HHS acquisition and program officials in determining whether proposed EIT supplies conform to applicable Section 508 accessibility standards. The template allows offerors or developers to self-evaluate their supplies and documentation detail - whether they conform to a specific Section 508 accessibility standard, and any underway remediation efforts addressing conformance issues.

Instructions for preparing the HHS Section 508 Evaluation Template are available under Section 508 policy on the HHS Web site http://hhs.gov/web/508.

(d) Respondents to this solicitation must identify any exception to Section 508 requirements. If an offeror claims its supplies or services meet applicable Section 508 accessibility standards, and it is later determined by the Government, i.e., after award of a contract or order, that supplies or services delivered do not conform to the accessibility standards, remediation of the supplies or services to the level of conformance specified in the contract will be the responsibility of the Contractor at its expense.

Work Requirement / Performance Standard

Acceptable Quality Level Surveillance Method

Incentive for Meeting Performance Standard

Perform of all tasks listed in the deliverables schedule

Deliverables provided in accordance with contract requirements, at an acceptable quality. 90% compliance within each contract period.

Surveillance by Assigned CDC Contracting Officer’s Representative

(COR)

- Negative or positive CPARS Evaluations

- Invoice reduction or non-payment for deliverables that do not meet contract requirements.

http://www.hhs.gov/web/508 http://www.access-board.gov/sec508/standards.htm https://www.hhs.gov/grants/contracts/contract-policies-regulations/hhsar/part-352-solicitation-provisions-contract-clauses/index.html#352.239-74 http://hhs.gov/web/508

(e) Electronic content must be accessible to HHS acceptance criteria. Checklist for various formats are available at http://508.hhs.gov/, or from the Section 508 Coordinator listed at https://www.hhs.gov/web/section- 508/additional-resources/section-508-contacts/index.html. Materials that are final items for delivery should be accompanied by the appropriate checklist, except upon approval of the Contracting Officer or Representative.

http://508.hhs.gov/ https://www.hhs.gov/web/section-508/additional-resources/section-508-contacts/index.html https://www.hhs.gov/web/section-508/additional-resources/section-508-contacts/index.html

SECTION D - CONTRACT CLAUSES

Section D-1 - Clauses Incorporated By Reference

D-1.1 52.252-2 Clauses Incorporated by Reference (Feb 1998) This contract incorporates one or more clauses by reference, with the same force and effect as if they were given in full text. Upon request, the Contracting Officer will make their full text available.

Also, the full text of a clause may be accessed electronically at this/these address(es):

https://www.acquisition.gov/browse/index/far https://www.ecfr.gov/current/title-48

(End of Clause)

FAR SOURCE TITLE DATE

52.204-9 Personal Identity Verification of Contractor Personnel Jan 2011

52.212-4 Contract Terms and Conditions—Commercial Products and Commercial Services

Dec 2022

52.227-14 Rights in Data-General May 2014

52.232-40 Providing Accelerated Payments to Small Business Subcontractors Mar 2023

HHSAR SOURCE TITLE DATE

352.203-70 Anti-Lobbying Dec 2015

352.208-70 Printing and Duplication Dec 2015

352.222-70 Contractor Cooperation in Equal Employment Opportunity Investigations

Dec 2015

Section D-2 - Clauses Incorporated In Full Text

D-2.1 FAR 52.212-5 Contract Terms and Conditions Required To Implement Statutes or Executive Orders— Commercial Products and Commercial Services (Mar 2023)

(a) The Contractor shall comply with the following Federal Acquisition Regulation (FAR) clauses, which are incorporated in this contract by reference, to implement provisions of law or Executive orders applicable to acquisitions of commercial products and commercial services:

(1) 52.203-19, Prohibition on Requiring Certain Internal Confidentiality Agreements or Statements (JAN 2017) (section 743 of Division E, Title VII, of the Consolidated and Further Continuing Appropriations Act, 2015 (Pub. L. 113-235) and its successor provisions in subsequent appropriations acts (and as extended in continuing resolutions)).

(2) 52.204-23, Prohibition on Contracting for Hardware, Software, and Services Developed or Provided by Kaspersky Lab and Other Covered Entities (NOV 2021) (Section 1634 of Pub. L. 115-91).

https://www.acquisition.gov/browse/index/far https://www.ecfr.gov/current/title-48 https://www.acquisition.gov/far/52.203-19#FAR_52_203_19 https://www.acquisition.gov/far/52.204-23#FAR_52_204_23

(3) 52.204-25, Prohibition on Contracting for Certain Telecommunications and Video Surveillance Services or Equipment. (NOV 2021) (Section 889(a)(1)(A) of Pub. L. 115-232).

(4) 52.209-10, Prohibition on Contracting with Inverted Domestic Corporations (NOV 2015).

(5) 52.232-40, Providing Accelerated Payments to Small Business Subcontractors (MAR 2023) ( 31 U.S.C.

3903 and 10 U.S.C. 3801).

(6) 52.233-3, Protest After Award (AUG 1996) ( 31 U.S.C. 3553).

(7) 52.233-4, Applicable Law for Breach of Contract Claim (OCT 2004) (Public Laws 108-77 and 108-78 ( 19 U.S.C. 3805 note)).

(b) The Contractor shall comply with the FAR clauses in this paragraph (b) that the Contracting Officer has indicated as being incorporated in this contract by reference to implement provisions of law or Executive orders applicable to acquisitions of commercial products and commercial services:

[Contracting Officer check as appropriate.]

X (1) 52.203-6, Restrictions on Subcontractor Sales to the Government (JUN 2020), with Alternate I (NOV 2021) ( 41 U.S.C. 4704 and 10 U.S.C. 4655).

X (2) 52.203-13, Contractor Code of Business Ethics and Conduct (NOV 2021) ( 41 U.S.C. 3509)).

__ (3) 52.203-15, Whistleblower Protections under the American Recovery and Reinvestment Act of 2009 (JUN 2010) (Section 1553 of Pub. L. 111-5). (Applies to contracts funded by the American Recovery and Reinvestment Act of 2009.)

X (4) 52.204-10, Reporting Executive Compensation and First-Tier Subcontract Awards (JUN 2020) (Pub. L. 109-

282) ( 31 U.S.C. 6101 note).

__ (5) [Reserved].

X (6) 52.204-14, Service Contract Reporting Requirements (OCT 2016) (Pub. L. 111-117, section 743 of Div. C).

__ (7) 52.204-15, Service Contract Reporting Requirements for Indefinite-Delivery Contracts (OCT 2016) (Pub. L.

111-117, section 743 of Div. C).

X (8) 52.209-6, Protecting the Government’s Interest When Subcontracting with Contractors Debarred, Suspended, or Proposed for Debarment. (NOV 2021) ( 31 U.S.C. 6101 note).

X (9) 52.209-9, Updates of Publicly Available Information Regarding Responsibility Matters (OCT 2018) ( 41 U.S.C. 2313).

__ (10) [Reserved].

__ (11) 52.219-3, Notice of HUBZone Set-Aside or Sole-Source Award (OCT 2022) ( 15 U.S.C. 657a).

__ (12) 52.219-4, Notice of Price Evaluation Preference for HUBZone Small Business Concerns (OCT 2022) (if the offeror elects to waive the preference, it shall so indicate in its offer) ( 15 U.S.C. 657a).

__ (13) [Reserved]

X (14) (i) 52.219-6, Notice of Total Small Business Set-Aside (NOV 2020) ( 15 U.S.C. 644).

__ (ii) Alternate I (MAR 2020) of 52.219-6.

__ (15) (i) 52.219-7, Notice of Partial Small Business Set-Aside (NOV 2020) ( 15 U.S.C. 644).

https://www.acquisition.gov/far/52.204-25#FAR_52_204_25 https://www.acquisition.gov/far/52.209-10#FAR_52_209_10 https://www.acquisition.gov/far/52.232-40#FAR_52_232_40 https://www.govinfo.gov/link/uscode/31/3903 https://www.govinfo.gov/link/uscode/31/3903 https://www.govinfo.gov/link/uscode/10/3801 https://www.acquisition.gov/far/52.233-3#FAR_52_233_3 http://uscode.house.gov/browse.xhtml;jsessionid=114A3287C7B3359E597506A31FC855B3 https://www.acquisition.gov/far/52.233-4#FAR_52_233_4 http://uscode.house.gov/browse.xhtml;jsessionid=114A3287C7B3359E597506A31FC855B3 https://www.acquisition.gov/far/52.203-6#FAR_52_203_6 http://uscode.house.gov/browse.xhtml;jsessionid=114A3287C7B3359E597506A31FC855B3 https://www.govinfo.gov/link/uscode/10/4655 https://www.acquisition.gov/far/52.203-13#FAR_52_203_13 http://uscode.house.gov/browse.xhtml;jsessionid=114A3287C7B3359E597506A31FC855B3 https://www.acquisition.gov/far/52.203-15#FAR_52_203_15 https://www.acquisition.gov/far/52.204-10#FAR_52_204_10 http://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title31-section6101&num=0&edition=prelim https://www.acquisition.gov/far/52.204-14#FAR_52_204_14 https://www.acquisition.gov/far/52.204-15#FAR_52_204_15 https://www.acquisition.gov/far/52.209-6#FAR_52_209_6 http://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title31-section6101&num=0&edition=prelim https://www.acquisition.gov/far/52.209-9#FAR_52_209_9 http://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title41-section2313&num=0&edition=prelim https://www.acquisition.gov/far/52.219-3#FAR_52_219_3 http://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title15-section637a&num=0&edition=prelim https://www.acquisition.gov/far/52.219-4#FAR_52_219_4 http://uscode.house.gov/browse.xhtml;jsessionid=114A3287C7B3359E597506A31FC855B3 https://www.acquisition.gov/far/52.219-6#FAR_52_219_6 http://uscode.house.gov/browse.xhtml;jsessionid=114A3287C7B3359E597506A31FC855B3 https://www.acquisition.gov/far/52.219-6#FAR_52_219_6 https://www.acquisition.gov/far/52.219-7#FAR_52_219_7 http://uscode.house.gov/browse.xhtml;jsessionid=114A3287C7B3359E597506A31FC855B3

__ (ii) Alternate I (MAR 2020) of 52.219-7.

X (16) 52.219-8, Utilization of Small Business Concerns (OCT 2022) ( 15 U.S.C. 637(d)(2) and (3)).

__ (17) (i) 52.219-9, Small Business Subcontracting Plan (OCT 2022) ( 15 U.S.C. 637(d)(4)).

__ (ii) Alternate I (NOV 2016) of 52.219-9.

__ (iii) Alternate II (NOV 2016) of 52.219-9.

__ (iv) Alternate III (JUN 2020) of 52.219-9.

__ (v) Alternate IV (SEP 2021) of 52.219-9.

__ (18) (i) 52.219-13, Notice of Set-Aside of Orders (MAR 2020) ( 15 U.S.C. 644(r)).

__ (ii) Alternate I (MAR 2020) of 52.219-13.

X (19) 52.219-14, Limitations on Subcontracting (OCT 2022) ( 15 U.S.C. 637s).

__ (20) 52.219-16, Liquidated Damages—Subcontracting Plan (SEP 2021) ( 15 U.S.C. 637(d)(4)(F)(i)).

__ (21) 52.219-27, Notice of Service-Disabled Veteran-Owned Small Business Set-Aside (OCT 2022) ( 15 U.S.C. 657f).

X (22) (i) 52.219-28, Post Award Small Business Program Rerepresentation (MAT 2023)( 15 U.S.C. 632(a)(2)).

__ (ii) Alternate I (MAR 2020) of 52.219-28.

__ (23) 52.219-29, Notice of Set-Aside for, or Sole-Source Award to, Economically Disadvantaged Women-Owned Small Business Concerns (OCT 2022) ( 15 U.S.C. 637(m)).

__ (24) 52.219-30, Notice of Set-Aside for, or Sole-Source Award to, Women-Owned Small Business Concerns Eligible Under the Women-Owned Small Business Program (OCT 2022) ( 15 U.S.C. 637(m)).

__ (25) 52.219-32, Orders Issued Directly Under Small Business Reserves (MAR 2020) ( 15 U.S.C. 644(r)).

__ (26) 52.219-33, Nonmanufacturer Rule (SEP 2021) ( 15U.S.C. 637(a)(17)).

X (27) 52.222-3, Convict Labor (JUN 2003) (E.O.11755).

__ (28) 52.222-19, Child Labor-Cooperation with Authorities and Remedies (DEC 2022) (E.O.13126).

X (29) 52.222-21, Prohibition of Segregated Facilities (APR 2015).

X (30) (i) 52.222-26, Equal Opportunity (SEP 2016) (E.O.11246).

__ (ii) Alternate I (FEB 1999) of 52.222-26.

X (31) (i) 52.222-35, Equal Opportunity for Veterans (JUN 2020) ( 38 U.S.C. 4212).

__ (ii) Alternate I (JUL 2014) of 52.222-35.

X (32) (i) 52.222-36, Equal Opportunity for Workers with Disabilities (JUN 2020) ( 29 U.S.C. 793).

__ (ii) Alternate I (JUL 2014) of 52.222-36.

X (33) 52.222-37, Employment Reports on Veterans (JUN 2020) ( 38 U.S.C. 4212).

https://www.acquisition.gov/far/52.219-7#FAR_52_219_7 https://www.acquisition.gov/far/52.219-8#FAR_52_219_8 http://uscode.house.gov/browse.xhtml;jsessionid=114A3287C7B3359E597506A31FC855B3 https://www.acquisition.gov/far/52.219-9#FAR_52_219_9 http://uscode.house.gov/browse.xhtml;jsessionid=114A3287C7B3359E597506A31FC855B3 https://www.acquisition.gov/far/52.219-9#FAR_52_219_9 https://www.acquisition.gov/far/52.219-9#FAR_52_219_9 https://www.acquisition.gov/far/52.219-9#FAR_52_219_9 https://www.acquisition.gov/far/52.219-9#FAR_52_219_9 https://www.acquisition.gov/far/52.219-13#FAR_52_219_13 http://uscode.house.gov/browse.xhtml;jsessionid=114A3287C7B3359E597506A31FC855B3 https://www.acquisition.gov/far/52.219-13#FAR_52_219_13 https://www.acquisition.gov/far/52.219-14#FAR_52_219_14 http://uscode.house.gov/browse.xhtml;jsessionid=114A3287C7B3359E597506A31FC855B3 https://www.acquisition.gov/far/52.219-16#FAR_52_219_16 http://uscode.house.gov/browse.xhtml;jsessionid=114A3287C7B3359E597506A31FC855B3 https://www.acquisition.gov/far/52.219-27#FAR_52_219_27 http://uscode.house.gov/browse.xhtml;jsessionid=114A3287C7B3359E597506A31FC855B3 https://www.acquisition.gov/far/52.219-28#FAR_52_219_28 http://uscode.house.gov/browse.xhtml;jsessionid=114A3287C7B3359E597506A31FC855B3 https://www.acquisition.gov/far/52.219-28#FAR_52_219_28 https://www.acquisition.gov/far/52.219-29#FAR_52_219_29 http://uscode.house.gov/browse.xhtml;jsessionid=114A3287C7B3359E597506A31FC855B3 https://www.acquisition.gov/far/52.219-30#FAR_52_219_30 http://uscode.house.gov/browse.xhtml;jsessionid=114A3287C7B3359E597506A31FC855B3 https://www.acquisition.gov/far/52.219-32#FAR_52_219_32 https://www.govinfo.gov/content/pkg/USCODE-2018-title15/html/USCODE-2018-title15-chap14A-sec644.htm https://www.acquisition.gov/far/52.219-33#FAR_52_219_33 https://www.govinfo.gov/content/pkg/USCODE-2018-title15/html/USCODE-2018-title15-chap14A-sec637.htm https://www.acquisition.gov/far/52.222-3#FAR_52_222_3 https://www.acquisition.gov/far/52.222-19#FAR_52_222_19 https://www.acquisition.gov/far/52.222-21#FAR_52_222_21 https://www.acquisition.gov/far/52.222-26#FAR_52_222_26 https://www.acquisition.gov/far/52.222-26#FAR_52_222_26 https://www.acquisition.gov/far/52.222-35#FAR_52_222_35 http://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title38-section4212&num=0&edition=prelim https://www.acquisition.gov/far/52.222-35#FAR_52_222_35 https://www.acquisition.gov/far/52.222-36#FAR_52_222_36 http://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title29-section793&num=0&edition=prelim https://www.acquisition.gov/far/52.222-36#FAR_52_222_36 https://www.acquisition.gov/far/52.222-37#FAR_52_222_37 http://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title38-section4212&num=0&edition=prelim

X (34) 52.222-40, Notification of Employee Rights Under the National Labor Relations Act (DEC 2010) (E.O.

13496).

X (35) (i) 52.222-50, Combating Trafficking in Persons (NOV 2021) ( 22 U.S.C. chapter 78 and E.O. 13627).

__ (ii) Alternate I (MAR 2015) of 52.222-50 ( 22 U.S.C. chapter 78 and E.O. 13627).

X (36) 52.222-54, Employment Eligibility Verification (MAY 2022) (Executive Order 12989). (Not applicable to the acquisition of commercially available off-the-shelf items or certain other types of commercial products or commercial services as prescribed in FAR 22.1803.)

__ (37) (i) 52.223-9, Estimate of Percentage of Recovered Material Content for EPA–Designated Items (May 2008) ( 42 U.S.C. 6962(c)(3)(A)(ii)). (Not applicable to the acquisition of commercially available off-the-shelf items.)

__ (ii) Alternate I (MAY 2008) of 52.223-9 ( 42 U.S.C. 6962(i)(2)(C)). (Not applicable to the acquisition of commercially available off-the-shelf items.)

__ (38) 52.223-11, Ozone-Depleting Substances and High Global Warming Potential Hydrofluorocarbons (Jun 2016) (E.O. 13693).

__ (39) 52.223-12, Maintenance, Service, Repair, or Disposal of Refrigeration Equipment and Air Conditioners (JUN 2016) (E.O. 13693).

__ (40) (i) 52.223-13, Acquisition of EPEAT®-Registered Imaging Equipment (JUN 2014) (E.O.s 13423 and 13514).

__ (ii) Alternate I (OCT 2015) of 52.223-13.

__ (41) (i) 52.223-14, Acquisition of EPEAT®-Registered Televisions (JUN 2014) (E.O.s 13423 and 13514).

__ (ii) Alternate I (Jun2014) of 52.223-14.

__ (42) 52.223-15, Energy Efficiency in Energy-Consuming Products (MAY 2020) ( 42 U.S.C. 8259b).

__ (43) (i) 52.223-16, Acquisition of EPEAT®-Registered Personal Computer Products (OCT 2015) (E.O.s 13423 and 13514).

__ (ii) Alternate I (JUN 2014) of 52.223-16.

X (44) 52.223-18, Encouraging Contractor Policies to Ban Text Messaging While Driving (JUN 2020) (E.O. 13513).

__ (45) 52.223-20, Aerosols (JUN 2016) (E.O. 13693).

__ (46) 52.223-21, Foams (Jun2016) (E.O. 13693).

__ (47) (i) 52.224-3 Privacy Training (JAN 2017) (5 U.S.C. 552 a).

__ (ii) Alternate I (JAN 2017) of 52.224-3.

__ (48) (i) 52.225-1, Buy American-Supplies (OCT 2022) ( 41 U.S.C. chapter 83).

__ (ii) Alternate I (OCT 2022) of 52.225-1.

__ (49) (i) 52.225-3, Buy American-Free Trade Agreements-Israeli Trade Act (DEC 2022) ( 19 U.S.C. 3301 note, 19 U.S.C. 2112 note, 19 U.S.C. 3805 note, 19 U.S.C. 4001 note, 19 U.S.C. chapter 29 (sections 4501-4732), Public Law 103-182, 108-77, 108-78, 108-286, 108-302, 109-53, 109-169, 109-283, 110-138, 112-41, 112-42, and 112-43.

__ (ii) Alternate I [Reserved].

https://www.acquisition.gov/far/52.222-40#FAR_52_222_40 https://www.acquisition.gov/far/52.222-50#FAR_52_222_50 http://uscode.house.gov/browse.xhtml;jsessionid=114A3287C7B3359E597506A31FC855B3 https://www.acquisition.gov/far/52.222-50#FAR_52_222_50 http://uscode.house.gov/browse.xhtml;jsessionid=114A3287C7B3359E597506A31FC855B3 https://www.acquisition.gov/far/52.222-54#FAR_52_222_54 https://www.acquisition.gov/far/22.1803#FAR_22_1803 https://www.acquisition.gov/far/52.223-9#FAR_52_223_9 http://uscode.house.gov/browse.xhtml;jsessionid=114A3287C7B3359E597506A31FC855B3 https://www.acquisition.gov/far/52.223-9#FAR_52_223_9 http://uscode.house.gov/browse.xhtml;jsessionid=114A3287C7B3359E597506A31FC855B3 https://www.acquisition.gov/far/52.223-11#FAR_52_223_11 https://www.acquisition.gov/far/52.223-12#FAR_52_223_12 https://www.acquisition.gov/far/52.223-13#FAR_52_223_13 https://www.acquisition.gov/far/52.223-13#FAR_52_223_13 https://www.acquisition.gov/far/52.223-14#FAR_52_223_14 https://www.acquisition.gov/far/52.223-14#FAR_52_223_14 https://www.acquisition.gov/far/52.223-15#FAR_52_223_15 http://uscode.house.gov/browse.xhtml;jsessionid=114A3287C7B3359E597506A31FC855B3…